Until the 20th century, drug manufacturers weren’t obliged to stick to standardized regulatory requirements, which meant uncomplicated production.
Things changed, and today, pharmaceutical manufacturers, research and testing laboratories, and distributors must consider regulatory requirements in order to avoid reputational and financial damage.
Pharma organizations are facing various challenges associated with inventory and production monitoring, equipment calibration, sanitary control, stability testing, clinical trials, and other industry-specific procedures. These require considerable resource-allocation, strategic planning, and non-stop, accurate monitoring.
In this short overview, we will be discussing equipment calibration and how to facilitate this procedure.
Drug manufacturers are using laboratory and production equipment, as well as automated analytical systems. Gauges, autoclaves, scales, centrifuges, chambers, refrigerators, pyrometers, tachometers, and other mechanical and electronic instruments must be routinely inspected and calibrated.
Pharmaceutical manufacturers neglecting accepted regulatory requirements deal with serious consequences. These include reputational and financial losses, as well as resource-intense legal proceedings.
Equipment calibration includes activities grouped into four phases:
- Design qualification
- Installation qualification
- Operational qualification
- Performance qualification
Equipment calibration must meet certain requisitions, outlined by:
- GMP Guidelines
- FDA 21 CFR part 211 CGMP
- FDA 21 CFR part 820 Quality System Regulation
- GAMP Good Practice Guide, Calibration Management
- USP General Chapter <1058>
One of the key legislative regulations in the United States is the FDA law by the Food & Drug Administration. The current FDA CGMP (Good Manufacturing Practice regulations) require the laboratory equipment to be properly calibrated at certain predefined intervals in accordance with an established program of scheduled routine inspections (21 CFR 211.68; 21 CFR 211.160).
According to the mentioned legislative standard:
- Laboratory and production equipment should be routinely calibrated and inspected to assure appropriate performance
- Any devices not meeting established specifications shall not be used
Other important industry regulations include GMP, GAMP, and USP standards.
As to GMP regulations:
- All equipment should be routinely calibrated and inspected
- All records should be maintained properly
- The statuses should be always known and verifiable
- The devices not meeting calibration criteria should not be used
According to GAMP regulations:
- Calibration documentation must be properly stored and retained
- Calibration records must include detailed information on potential, procedures used, test conducted, as well as dates and signatures
According to USP regulations:
- Drug manufacturers must establish appropriate practices to address equipment calibration
- Pharmaceutical manufacturers must maintain supportive documentation
Optical character recognition to process documentation
Most importantly, poorly performed routine checkups might cause potential danger to the consumer’s health. If the utilized devices aren’t reliable, the finished pharmaceutical products are likely therapeutically inefficient and harmful.
What’s more, irresponsibly conducted obligatory inspections might provoke reputational and financial damage. If the used apparatus isn’t applicable, the liable pharmaceutical company might lose considerable resources repeatedly inspecting, servicing, calibration, or replacing that apparatus.
Since most pharmaceutical manufacturers and distributors are not yet ready to abandon handwritten records, equipment examination as well as calibration comes with traditionally paper-based supportive documentation. And with handwritten records, the digitization as well as centralization of important control parameters becomes intricate and inefficient.
What’s more, pharma companies usually don’t have specially assigned people to perform process validation. This causes human error, heavy workloads, employee dissatisfaction, and respectively low productivity.
In brief, handwritten records are causing serious problems, which include:
- Data inconsistency, fallibility, absence, or duplication
- Heavy workloads, employee dissatisfaction, and rather low productivity
- Communication and cooperation burdens
- Reputational and financial losses
To keep handwritten records but boost overall efficiency, we suggest:
- To stick to the familiar routine to avoid additional training
- To automate data entry, data processing and centralization, and analytics
Optical character recognition technology is the automatic translation of paper-based, handwritten documents. This process typically comprises three stages — text segmentation, feature extraction, and classification.
Handwritten text recognition software can extract necessary information from dissimilar, handwritten sources. By automating manual routines, this approach reduces risks, increases accuracy, and boosts business growth.
OCR technology can be successfully integrated across industries, in particular in the pharmaceutical segment. The benefits are significant — data validity and consolidation, record traceability and accessibility, and more.
OCR software can be custom designed and developed to meet the needs of the pharmaceutical manufacturer. For example, having performed routine inspection, the technician can scan the records, and the trained system will extract and transfer the information to the centralized database.
The solution can help efficiently monitor control parameters:
- Equipment performance
- Equipment statuses
- Examination schedule
- Examination frequency
- Calibration documentation
- Recalibration correspondence
The software can also be trained to process:
- Supportive documentation with different, patchy layouts
- Table content
- Low-quality records
- Offset and rotated records
We see unlimited potential and benefits in implementing advanced technology in the pharmaceutical industry. Business activities commonly requiring significant resource-allocation can be greatly optimized by adopting artificial intelligence.
There are already multiple success stories showing how digital innovation can help pharmaceutical companies. Notably minimized business risks — research time and cost, patent expiration, pricing issues — associated with drug discovery and development are just one example of how artificial intelligence is changing the world.
If there is one single thing pharmaceutical organizations should never ever compromise, it is product quality. Any inconsistencies can cause reputational and financial damage, not to mention more serious consequences.
To ensure appropriate quality, pharmaceutical companies must conduct equipment inspection and calibration. And here’s where traditionally handwritten records might cause considerable issues.
By using OCR technology, drug manufacturers can easily:
- Access critical equipment/calibration information
- Review current equipment/calibration statuses
- Receive notifications
- Schedule calibration, recalibration, service, and procurement
This way, OCR software can streamline:
- Data validity and consolidation
- Record traceability and accessibility
- Easy maintenance
- Regulatory compliance
- Thought-out workloads
- Employee satisfaction
- Reduced time and cost
- Increased productivity and profitability
Summing up, advanced technology shows significant business potential and opportunities across industries. Smart solutions are already being implemented in healthcare, finance, education, distribution, construction, and other large domains.
No wonder digital innovation is among the biggest trends today, both among business leaders and consumers. We see more and more companies providing custom software product development services, which comprise OCR, HTR, and other modern techniques.
We can now automate various processes: